Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have imp...
FDA Device Recall #Z-0272-2023 — Class II — October 10, 2022
Recall Summary
| Recall Number | Z-0272-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 10, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Smiths Medical ASD Inc. |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 422 devices |
Product Description
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.
Reason for Recall
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
Distribution Pattern
US distribution to states of: Indiana, Texas and Virginia
Lot / Code Information
Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01 UDI: 501951706962; Serial #'s 2033844 2033845 2033846 2033850 2033851 2033852 2033854 2033856 2033857 2033858 2033859 2033861 2033862 2033864 2033865 2033866 2033867 2033871 2033875 2033877 2033878 2033880 2033982 2033984 2034104 2034106 2034107 2034108 2034109 2034110 2034113 2034115 2034116 2034117 2034118 2034120 2034123 2034124 2034125 2034126 2034129 2034131 2034132 2034133 2034134 2034135 2034136 2034137 2034138 2034139 2034140 2034141 2034142 2034143 2034144 2034145 2034146 2034147 2034148 2034149 2034150 2034151 2034152 2034153 2034154 2034155 2034201 2034202 2034204 2034205 2034222 2034223 2034224 2034225 2035182 2035183 2035184 2035185 2035186 2035187 2035188 2035190 2035191 2035193 2035194 2035195 2035196 2035197 2035198 2035200 2035201 2035202 2035203 2035204 2035205 2035206 2035207 2035209 2035210 2035212 2035214 2035216 2035217 2035218 2035811 2035812 2035813 2035814 2035815 2035816 2035817 2035819 2035820 2035821 2035826 2035827 2035828 2035829 2035830 2035832 2035851 2035852 2035853 2035854 2037161 2033881 2033981 2038674 2038675 2038676 2038677 2038678 2038679 2038680 2038681 2038683 2038685 2038686 2038687 2038688 2038689 2038690 2038691 2038692 2038693 2038694 2038695 2038696 2035850 2034112 2034114 2034121 2035818 2033855 2034119 2035189 2035211 2033849 2035192 2035199 2035208 2035809 2035822 2035824 2035810 2035808 2035825 2035823 2035831 2038682 2033872 2033869 2033874 2033860 2025796 2025826 2046165 2046167 2046168 2046169 2046170 2046171 2046172 2046173 2046174 2046175 2046176 2046177 2046178 2046179 2046181 2046182 2046185 2025809 2038684 2033876 2067955 2067957 2067960 2067961 2067963 2067964 2067965 2067966 2067967 2067968 2067969 2067971 2067972 2067973 2067974 2067975 2067976 2067978 2067980 2067981 2067982 2067983 2067984 2067985 2067987 2067989 2067991 2067993 2067994 2067995 2067996 2067997 2067998 2067999 2068000 2068001 2068003 2068007 2068008 2068010 2068011 2068012 2068013 2068014 2068015 2068017 2068019 2068021 2068022 2068023 2068024 2068025 2068027 2068028 2068029 2068031 2068032 2068033 2068034 2068037 2068038 2068039 2068040 2068042 2068043 2068044 2068046 2068048 2068049 2068053 2068054 2068055 2068056 2068058 2068059 2068060 2068061 2068062 2068063 2068064 2068065 2068067 2068068 2068069 2068071 2068072 2068073 2068077 2068078 2068079 2068081 2068082 2068083 2068084 2068085 2068086 2068088 2068089 2068090 2068091 2068092 2068093 2068094 2068096 2068097 2068098 2068099 2068100 2068102 2068103 2068106 2068107 2068108 2068109 2068110 2068111 2068112 2068113 2068114 2068115 2068116 2068117 2068118 2068272 2068516 2068517 2068518 2068519 2068535 2068536 2068543 2068547 2068549 2069708 2069709 2069710 2068651 2068652 2068741 2068742 2068772 2067992 2068857 2068881 2068938 2068939 2068940 2068943 2068944 2068945 2068946 2035213 2069381 2069431 2069432 2069433 2067970 2068941 2068035 2068020 2046180 2068075 2070960 2068005 2068080 2070972 2070973 2068548 2068004 2068786 2068653 2033879 2068006 2068045 2068937 2068942 2068030 2068105 2068544 2068052 2068009 2068066 2046184 2068047 2068076 2033847 2069434 2068104 2068041 2033870 2068050 2046183 2067959 2033848 2034206 2033853 2025806 2025812 UDI: 501951707075; Serial #'s 2028673 2044037 2020917 2032957 2037477 2040070 2041392 2041527 2041668 2049487 2006685 2006717 2006750 2008582 2008620 2047401 2049022 2049927 2049932 2049934 2049941 2060111 2060405 2060441 2061199 2067962 2067977 2067988
Other Recalls from Smiths Medical ASD Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0147-2025 | Class II | smiths medical portex, Thermovent 1200, 15mm/22... | Jul 18, 2024 |
| Z-0145-2025 | Class II | smiths medical portex, Y' PIECE 15MM, REF 100/2... | Jul 18, 2024 |
| Z-0146-2025 | Class II | smiths medical portex, 'ORATOR' SPEAKING VALVE ... | Jul 18, 2024 |
| Z-0143-2025 | Class II | smiths medical portex, Nasopharyngeal Airway, S... | Jul 18, 2024 |
| Z-0144-2025 | Class II | smiths medical portex, 15mm Double Swivel Conne... | Jul 18, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.